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Evaluation of the Accuracy of the $EasyTest^{TM}$ Malaria Pf/Pan Ag, a Rapid Diagnostic Test, in Uganda

  • Chong, Chom-Kyu (GenBody Inc.) ;
  • Cho, Pyo Yun (Department of Parasitology and Tropical Medicine and Inha Research Institute for Medical Sciences, Inha University School of Medicine) ;
  • Na, Byoung-Kuk (Department of Parasitology and Tropical Medicine, Institute of Health Sciences, Gyeongsang National University School of Medicine) ;
  • Ahn, Seong Kyu (Department of Parasitology and Tropical Medicine and Inha Research Institute for Medical Sciences, Inha University School of Medicine) ;
  • Kim, Jin Su (Department of Parasitology and Tropical Medicine and Inha Research Institute for Medical Sciences, Inha University School of Medicine) ;
  • Lee, Jin-Soo (Department of Internal Medicine, Inha University School of Medicine) ;
  • Lee, Sung-Keun (Department of Pharmacology, Inha University School of Medicine) ;
  • Han, Eun-Taek (Department of Medical Environmental Biology and Tropical Medicine, School of Medicine, Kangwon National University) ;
  • Kim, Hak-Yong (Department of Biochemistry & CBITRC, Chungbuk National University) ;
  • Park, Yun-Kyu (Department of Parasitology and Tropical Medicine and Inha Research Institute for Medical Sciences, Inha University School of Medicine) ;
  • Cha, Seok Ho (Department of Parasitology and Tropical Medicine and Inha Research Institute for Medical Sciences, Inha University School of Medicine) ;
  • Kim, Tong-Soo (Department of Parasitology and Tropical Medicine and Inha Research Institute for Medical Sciences, Inha University School of Medicine)
  • Received : 2013.11.14
  • Accepted : 2014.07.14
  • Published : 2014.10.31

Abstract

In recent years, rapid diagnostic tests (RDTs) have been widely used for malaria detection, primarily because of their simple operation, fast results, and straightforward interpretation. The Asan $EasyTest^{TM}$ Malaria Pf/Pan Ag is one of the most commonly used malaria RDTs in several countries, including Korea and India. In this study, we tested the diagnostic performance of this RDT in Uganda to evaluate its usefulness for field diagnosis of malaria in this country. Microscopic and PCR analyses, and the Asan $EasyTest^{TM}$ Malaria Pf/Pan Ag rapid diagnostic test, were performed on blood samples from 185 individuals with suspected malaria in several villages in Uganda. Compared to the microscopic analysis, the sensitivity of the RDT to detect malaria infection was 95.8% and 83.3% for Plasmodium falciparum and non-P. falciparum, respectively. Although the diagnostic sensitivity of the RDT decreased when parasitemia was ${\leq}500\;parasites/{\mu}l$, it showed 96.8% sensitivity (98.4% for P. falciparum and 93.8% for non-P. falciparum) in blood samples with parasitemia ${\geq}100\;parasites/{\mu}l$. The specificity of the RDT was 97.3% for P. falciparum and 97.3% for non-P. falciparum. These results collectively suggest that the accuracy of the Asan $EasyTest^{TM}$ Malaria Pf/Pan Ag makes it an effective point-of-care diagnostic tool for malaria in Uganda.

Keywords

References

  1. World Health Organization. World Malaria Report 2011. Available from http://www.who.int/topics/malaria/en/.
  2. USAID. The Malaria End-Use Verfication (EUV) Report 2010. Available from http://sure.ug/?Publications.
  3. World Health Organization. New perspectives: malaria diagnosis. Report of a Joint WHO/USAID Informal Consultation 2010. WHO/MAL/2000.1091.
  4. Moody A. Rapid diagnostic tests for malaria parasites. Clin Microbiol Rev 2002; 15: 66-78. https://doi.org/10.1128/CMR.15.1.66-78.2002
  5. Benito A, Roche J, Molina R, Amela C, Altar J. Application and evaluation of $QBC^{(R)}$ malaria diagnosis in a holoendemic area. Appl Parasitol 1994; 35: 266-272.
  6. World Health Organization. Management of uncomplicated malaria and the use of antimalarial drugs for the protection of travellers. Report of an Informal Consultation 1996. WHO/MAL/96.
  7. Molyneux M, Fox R. Diagnosis and treatment of malaria in Britain. BMJ 1993; 306: 1175-1179. https://doi.org/10.1136/bmj.306.6886.1175
  8. McKenzie FE, Sirichaisinthop J, Miller RS, Gasser RA Jr, Wongsrichanalai C. Dependence of malaria detection and species diagnosis by microscopy on parasite density. Am J Trop Med Hyg 2003; 69: 372-376.
  9. Lee GC, Jeon ES, Le DT, Kim TS, Yoo JH, Kim HY, Chong CK. Development and evaluation of a rapid diagnostic test for Plasmodium falciparum, P. vivax, and mixed-species malaria antigens. Am J Trop Med Hyg 2011; 85: 989-993. https://doi.org/10.4269/ajtmh.2011.11-0265
  10. Chilton D, Malik ANJ, Armstrong M, Kettelhut M, Parker-Williams J, Chiodini PL. Use of rapid diagnostic tests for diagnosis of malaria in the UK. J Clin Pathol 2006; 59: 862-866. https://doi.org/10.1136/jcp.2005.032904
  11. Kain KC, Brown AE, Mirabelli L, Webster HK. Detection of Plasmodium vivax by polymerase chain reaction in a field study. J Infect Dis 1993; 168: 1323-1326. https://doi.org/10.1093/infdis/168.5.1323
  12. Kain KC, Kyle DE, Wongrichanalai C, Brown AE. Qualitative and semi-quantitative polymerase chain reaction to predict Plasmodium falciparum treatment failure. J Infect Dis 1994; 170: 1626-1630. https://doi.org/10.1093/infdis/170.6.1626
  13. Rock EP, Marsh K, Saul SJ, Wellems TE, Taylor DW, Maloy WL, Howard RJ. Comparative analysis of the Plasmodium falciparum histidine-rich proteins HRP1, HRP2 and HRP3 in malaria diagnosis of diverse origin. Parasitology 1987; 95: 209-227. https://doi.org/10.1017/S0031182000057681
  14. Makler MT, Piper RC, Milhous WK. Lactate dehydrogenase and the diagnosis of malaria. Parasitol Today 1998; 14: 376-377. https://doi.org/10.1016/S0169-4758(98)01284-8
  15. Meier B, Dobeli H, Certa U. Stage-specific expression of aldolase isoenzymes in the rodent malaria parasite Plasmodium berghei. Mol Biochem Parasitol 1992; 52: 15-27. https://doi.org/10.1016/0166-6851(92)90032-F
  16. De Dominguez N, Rodriguez-Acosta A. Glutamate dehydrogenase antigen detection in Plasmodium falciparum infections. Korean J Parasitol 1996; 34: 239-246. https://doi.org/10.3347/kjp.1996.34.4.239
  17. Piper R, Lebras J, Wentworth L, Hunt-Cooke A, Houze S, Chiodini P, Makler M. Immunocapture diagnostic assays for malaria using Plasmodium lactate dehydrogenase (pLDH). Am J Trop Med Hyg 1999; 60: 109-118.
  18. Quintana M, Piper R, Boling HL, Makler M, Sherman C, Gill E, Fernandez E, Martin S. Malaria diagnosis by dipstick assay in a Honduran population with coendemic Plasmodium falciparum and Plasmodium vivax. Am J Trop Med Hyg 1998; 59: 868-871.
  19. Shiff CJ, Premji Z, Minjas JN. The rapid manual ParaSight-$F^{(R)}$ test. A new diagnostic tool for Plasmodium falciparum infection. Trans R Soc Trop Med Hyg 1993; 87: 646-648. https://doi.org/10.1016/0035-9203(93)90273-S
  20. Tjitra E, Suprianto S, Dyer M, Currie BJ, Anstey NM. Field evaluation of the ICT malaria P.f/P.v immunochromatographic test for detection of Plasmodium falciparum and Plasmodium vivax in patients with a presumptive clinical diagnosis of malaria in eastern Indonesia. J Clin Microbiol 1999; 37: 2412-2417.
  21. World Health Organization. Monitoring antimalarial drug resistance. Report of WHO Consultation 2001. WHO/CDS/CSR/EPH/2002.7.
  22. Warhurst DC, Williams JE. Laboratory diagnosis of malaria. J Clin Pathol 1996; 49: 533-538. https://doi.org/10.1136/jcp.49.7.533
  23. Brown AE, Kain KC, Pipithkul J, Webster HK. Demonstration by the polymerase chain reaction of mixed Plasmodium falciparum and P. vivax infections undetected by conventional microscopy. Trans R Soc Trop Med Hyg 1992; 86: 609-612. https://doi.org/10.1016/0035-9203(92)90147-5
  24. World Health Organization. Malaria rapid diagnosis: making it work. Meeting Report January 20-23. Manila, 2003.
  25. Bell D, Wongsrichanalai C, Barnwell JW. Ensuring quality and access for malaria diagnosis: how can it be achieved? Nat Rev Microbiol 2006; 4: 682-695. https://doi.org/10.1038/nrmicro1474
  26. Grobusch MP, Alpermann U, Schwenke S, Jelinek T, Warhurst DC. False-positive rapid tests for malaria in patients with rheumatoid factor. Lancet 1999; 353: 297.
  27. Humar A, Ohrt C, Harrington MA, Pillai D, Kain KC. $ParaSight^{(R)}$ F test compared with the polymerase chain reaction and microscopy for the diagnosis of Plasmodium falciparum malaria in travelers. Am J Trop Med Hyg 1997; 56: 44-48.
  28. Mayxay M, Pukrittayakamee S, Newton PN, White NJ. Mixed-species malaria infections in humans. Trends Parasitol 2004; 20: 233-240. https://doi.org/10.1016/j.pt.2004.03.006
  29. Co EMA, Dennull RA, Reinbold DD, Waters NC, Johnson JD. Assessment of malaria in vitro drug combination screening and mixed-strain infections using the malaria Sybr green I-based fluorescence assay. Antimicrob Agents Chemother 2009; 53: 2557-2563. https://doi.org/10.1128/AAC.01370-08

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